Direct Hire - Associate Director, Quality Systems & Materials job Exton Pennsylv
Direct Hire - Associate Director, Quality Systems & Materials job Exton Pennsylv
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Direct Hire - Associate Director, Quality Systems & Materials Job



Employer Name: SpiderID: 7766044
Location: Exton, Pennsylvania Date Posted: 7/19/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH27416

Job Description:

Job Summary



  • The Associate Director, Quality Systems & Materials directly manages teams that oversee Quality Systems, Materials, Document Control and CMO program Management within this human health care pharmaceutical company.

  • The teams have the following responsibilities: 1. Quality Systems oversight a. Business Owner, Lab Administrator, and Quality Contact of LIMS b. System Owner and Quality Contact of TrackWise c. Quality contact for SAP d. Administration for Exton SharePoint 2. Materials oversight for both clinical and commercial operations a. Disposition of incoming goods used in the Biologics facility b. Disposition of products manufactured in the Biologics facility 3. Document Control for the Biologics facility 4. CMO Quality oversight a. Cell banking b. Bulk Drug Substance c. Packaging, labeling, and Distribution d. External Testing Laboratories


Responsibilities



  • Directly manage teams that oversee Quality Systems, Materials, Document Control, and CMO Program Management

  • Direct department activities related to planning and implementation of continuous improvement of Quality Systems

  • Provide guidance and leadership to the DQA team to ensure decisions are made using regulatory knowledge, industry standard practices, engineering and scientific principles, and technical knowledge

  • As Deputy Quality Site Head, lead and be responsible for Quality Assurance activities when the Sr Director is not available

  • The Associate Director also acts as Deputy Quality Head, partnering with the Sr. Director Development Quality Assurance-US (DQA-US) to lead and be responsible for Quality Assurance for: (a) all clinical and commercial GxP biologic activities overseen by the Quality Assurance team in Exton; (b) all GMP activities at Contract manufacturing, testing, packaging, and distribution organizations for US clinical trials (small molecules); and (c) companion diagnostic activities. This role is responsible for all aspects of GxP Quality Assurance, including ensuring appropriate operating philosophies, Quality Culture, staffing, and Quality Systems align with Company Global Standards and international cGMP regulations.


Qualifications
Education



  • BS in Life Sciences or equivalent


Experience



  • At least 10 years' experience in a cGMP environment

  • At least 5 years leadership experience in a Quality organization

  • Experience with Quality Systems (LIMS, SAP, TrackWise)

  • Knowledgeable in biologics manufacturing

  • Knowledgeable in FDA, EU and JP CMC regulations for both clinical and commercial operations

  • Leadership experience implementing complex systems and interacting with diverse and international multidisciplinary teams


Skills



  • Possess a hands-on proactive stance with excellent interpersonal skills and a willingness and ability to assist all team members to achieve the project goals

  • Ability to set priorities and achieve goals; strategic thinking, energy, and enthusiasm

  • Excellent interpersonal skills

  • Excellent written and communication skills

  • Ability to supervise, mentor, train, and develop staff

  • Auditing skills preferred




Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.

Approx. Duration: Perm

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: http://bit.ly/HbMCareers



Job Criteria:
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Position Type: Full-Time Permanent
Years of Experience Required:
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